Mylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
Mylan Pharmaceuticals is recalling Acamprosate Calcium tablets that failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles. The recall is due to the product failing to meet dissolution specifications. The affected product is identified by Lot# 3227809, NDC 0378-6333-80, and an expiry date of 10/2026.
The recall covers distribution across the US Nationwide. The product is a prescription-only medication manufactured by Mylan Pharmaceuticals Inc. in Morgantown, WV.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED)
- Brand
- ACAMPROSATE CALCIUM
- Manufacturer
- Mylan Pharmaceuticals Inc
- Category
- Drug — Prescription Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot# 3227809
- Expiry:10/2026
- NDC #: 0378-6333-80
UPCs (1)
- 0303786333806
Distribution
Distributed nationwide across the United States.
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